Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone. we never expected to actually to connect with other people in the blogging community.
we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!
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Despite US legislation in 2010 that moved the country closer to achieving universal healthcare, costs have continued to rise and nearly 26 million Americans are still uninsured according to the Congressional Budget Office.
As Republicans decide whether to repeal or replace the struggling healthcare policy, how does the existing US healthcare system compare with those in other countries?
Broadly speaking, the World Health Organization (WHO) defines universal health coverage as a system where everyone has access to quality health services and is protected against financial risk incurred while accessing care.
A brief history of the healthcare systems used today
Among the 35 OECD member countries, 32 have now introduced universal healthcare legislation that resembles the WHO criteria.
Spending compared with life expectancy
Life expectancy in the US is still lower than other developed countries, despite health funding increasing at a much faster pace.
Who provides healthcare and how is it paid for?
How healthcare is funded has a direct effect on the level of healthcare people have access to.
How could the US healthcare system change?
Donald Trump ran on a campaign to repeal and replace the Affordable Care Act, popularly known as Obamacare, but discord among Republicans has highlighted the political challenges faced with implementing a healthcare system, much less trying to change it.
With millions still uninsured and the financial burden of healthcare still quite high, the current US policy falls short of the WHO threshold.
Thus far, separate bills introduced in the House and the Senate were estimated to see steep increases in the number of uninsured from current levels.
Estimated uninsured under existing and proposed healthcare plans